GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) BD MAX¿ STAPHSR; SYSTEM, NUCLEIC ACID AMPLIFICATION TEST, DNA, METHICILLIN RESISTANT STAPHYLOCOCC
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Catalog Number 443419 |
Device Problem
False Negative Result (1225)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/26/2023 |
Event Type
malfunction
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Event Description
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It was reported that while using bd max¿ staphsr, there were 3 false negative results.No patient impact reported.The following information was provided by the initial reporter: "channel mrej neg, but nuc and meca positive - mrsa confirmed.".
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Manufacturer Narrative
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E.1.Initial reporter prefix: (b)(6) dr.D.2b.Medical device type: ooi.H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
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Event Description
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Report 1 of 3.It was reported that while using bd max¿ staphsr, there were 1 false negative of a patient sample.No patient impact reported.The following information was provided by the initial reporter: "accession number: (b)(4) in 3 independent patient samples, it was found during internal laboratory confirmation of mrsa strains already detected in culture that the bd max staph sr kit reliably detects staphylococcus aureus (nuc gene channel 530/565) and the meca & mecc gene (resistance meca&mecc gene channel 585/630), but the 11 mrej types cassette (11 mrej types channel 475/520) remains negative and the device therefore assesses the detection of mrsa as negative.This is possible in principle due to genetic variability, but there is currently an unusual accumulation of these cases in our laboratory.No false negative results were transmitted and no findings had to be corrected.".
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Manufacturer Narrative
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H.6.Investigation summary: the complaint investigation for discrepant results when using the kit bd max¿ staphsr (ref.(b)(4) ) lot 2270650 was performed by the review of the manufacturing records, retain material testing, review of customer¿s data and verification of complaints history.Review of the manufacturing records of bd max staphsr indicated that lot 2270650 was manufactured according to specifications and met performance requirements.The retain material of bd max staphsr from lot 2270650 was tested and the results met the specifications.Customer complained about three samples that gave false negative result with the bd max¿ staphsr assay; the meca/mecc as well as the nuc targets were detected but not the mrej target.According to the customer, samples were identified as mrsa.One picture and three run files (1016, 1018 and 1027 from instrument ct0480) were provided for investigation.The picture shows a bd max¿ staphsr kit from lot 2270650, confirming the lot number mentioned by the customer.Manual pcr curve adjudication was performed across the runs provided.Pcr analysis of three samples revealed no amplification in the fam channel (mrej target) and strong amplification in the vic channel (sa target) as well as in the rox channel (meca/c target).To be detected as mrsa positive with the bd max¿ staphsr assay, a sample must be positive for both the mrej and the meca/c targets.As mentioned in the package insert p0207, the bd max¿ staphsr assay is designed to detect mrej genotypes i, ii, iii, iv, v, vi, vii, ix, xiii, xiv, and xxi which represent most of mrsa strains harboring meca and mecc genes (belonging to different sccmec/mrej types) accounting for more than 98% of worldwide strains tested by bd to date.The investigation suggests that the customer strain may correspond to a mrej type undetected by the bd max¿ staphsr assay.Without analysis of the customer strain, bd was unable to confirm the customer issue.There is no indication of a reagent issue based on the analysis of the complaints received for discrepant results on the bd max staphsr assay from lot 2270650.The root cause was not identified.Bd acknowledge the customer issue but cannot confirm the complaint based on the investigation that was performed.Bd did not initiate a corrective and preventive action (capa) since no new hazard was identified.
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Manufacturer Narrative
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The following fields have been updated with corrected and/or additional information.B3: date of event has been updated from 2023-09-02 to 2023-07-26.B.5.Describe event or problem: update has been made to include patient details and additional information.
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Event Description
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Report 1 of 3.It was reported that while using bd max¿ staphsr, there were 1 false negative of a patient sample.No patient impact reported.The following information was provided by the initial reporter: "accession number: (b)(6).In 3 independent patient samples, it was found during internal laboratory confirmation of mrsa strains already detected in culture that the bd max staph sr kit reliably detects staphylococcus aureus (nuc gene channel 530/565) and the meca & mecc gene (resistance meca&mecc gene channel 585/630), but the 11 mrej types cassette (11 mrej types channel 475/520) remains negative and the device therefore assesses the detection of mrsa as negative.This is possible in principle due to genetic variability, but there is currently an unusual accumulation of these cases in our laboratory.No false negative results were transmitted and no findings had to be corrected.".
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Search Alerts/Recalls
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